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The UK Advertising Standards Authority (ASA) ruled this week that claims such as, “helps maintain Brain Function & Performance” for the product, Neurozan, were unsubstantiated, despite EFSA issuing positive cognitive function opinions for both vitamin B12 and B6.
Relevant?
Senior brand manager at Vitabiotics, Meghna Shah said her company had alerted the ASA to the positive opinions as they were, “relevant and related to B vitamins and brain function”.
“We detailed EFSA approved claims in our response, therefore supporting the overall message of the advert,” she told NutraIngredients.
“The ASA draft, however, did not incorporate this element of our response regarding the EFSA claims.”
The agency she said, determined that, ‘those EFSA claims do not have legal status until they are ratified by the EC’ and therefore was unable to consider them.
The ASA was not available for further comment at the time of publication.
Of vitamin B12, EFSA’s health claims panel stated:
“Vitamin B12 has a central role in the normal functions of the brain and nervous system. It is well established from clinical studies that vitamin B12 deficiency produces adverse neurological and psychological effects.
“The Panel concludes that a cause and effect relationship has been established between the dietary intake of vitamin B12 and contribution to normal neurological and psychological functions.”
The full vitamin B12 opinion can be found here.
One of the Neurozan formulas contained a cocktail of ingredients that included vitamin B12 at 4000 times the EU recommended daily allowance.
Other nutrients included vitamins B1,2,3 and 6, vitamin D3, co-enzyme Q10, 5-HTP, L-arginine, phosphatidylserine, ginkgo biloba and glutamine.
Non-healthy population data
In its ruling that revolved around assertions in some of Vitabiotic’s advertising to “recent research” the ASA focused on a randomised, double-blinded, controlled trial which it said failed to back the brain claims because it was underpowered and because the subjects were not healthy adults.
The trial gave over-70s with mild cognitive impairment (MCI) high dose supplements containing folic acid (vitamin B9) and vitamins B6 and B12 and found a statistically significant reduction in brain atrophy rates.
The ASA said: “We noted the 168 study participants were all aged over 70 and had a diagnosis of MCI, and that some participants had other health concerns such as diabetes and history of strokes, and we therefore considered that the study was unsuitable to support claims likely to be understood as referring to the normal, healthy adult population.”
The trial was not powered for cognition or cognitive decline, it said. “We therefore also considered that the study was not suitable to support claims relating to brain function or mental performance.”
4 comments (Comments are now closed)
Procedure
Obviously the applicant have forgotten that the EFSA scientific opinion becomes a valid health claim only after the approval of EC and the legal procedure might take a year.
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Posted by Inka H.
31 May 2011 | 11h41
B12 in a mix
CF book, Could It Be B12? by two Americans, Sally M. Pacholok, R.N., and Jeffrey J. Stuart, D.O.
The authors say there is a current and hidden epidemic of B12 deficiency. A very broad-based problem.
Seems unlikely a mix such as one named with phophotydlserine would be good for small children or for everyone needing supplemental B12.
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Posted by Anne Quick
23 April 2011 | 01h25
ASA decision
The full ASA decision can be found here:
http://asa.org.uk/ASA-action/Adjudications/2011/4/Vitabiotics-Ltd/TF_ADJ_50071.aspx
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Posted by ZeePrime
14 April 2011 | 01h05
Product or ingredient claim?
Consideration should be given regarding whether the advert was making a product claim vs. ingredient claim.
If as the ASA adjudication seems to indicate that it is a product claim then the evidence in support of the claim by Vitabiotics and any subsequent reference to EFSA should be related to a specific 13.5 claim and not 13.2.
There seems to be no indication that the product made clear that its marketing claims on cognitive/brain function was related to a specific ingredient and not the product. As such their defense was poorly constructed in this instance. Furthermore, the case was made worse by the use of a study which had little relevance to the general population. If a correlation was possible between the subjects in the trial and the general population this should have been made evident and made clear with evidence.
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Posted by Dr Mark J. Tallon, PhD
07 April 2011 | 15h40
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